To Confirm Equivalent Bronchodilator Efficacy of the Test Product Compared to the Reference Product

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to confirm equivalent bronchodilator efficacy of the test product compared to the reference product.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orion Corporation, Orion Pharma
• Treatments: Bronchodilator Agents; Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Formoterol Fumarate

Criteria

Main inclusion criteria:

• Written informed consent

• Asthma diagnosis for at least 6 months

• Prebronchodilator FEV1 45-90% of the predicted value

• Demonstration of reversible airway obstruction

• Stable asthma on the same regular treatment for at least 4 weeks before the study

• Non-smoker for at least 6 months before the study

Main exclusion criteria

• Respiratory infection within 4 weeks before the study

• Smoking history of more than 10 pack-years

• Other severe chronic respiratory disease than asthma

• Concurrent illness that would interfere with the interpretation of the study results or constitute a health risk for the patient if he/she takes part in the study

• Corrected QT interval > 450 ms in males or > 470 ms in females

• Abnormal serum potassium value or other clinically significant laboratory finding

• Systolic blood pressure over 180 mmHg and/or diastolic blood pressure over 100 mmHg

• Treatment with a long-acting β2-agonist, a xanthine-derivative, a β-blocker or with a corticosteroid (other than inhaled) within 4 weeks before the study

• Use of drugs that prolong QT-interval

• Women who are pregnant, breast-feeding or without reliable contraception

• Participation in another clinical drug study